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For Enteral Feeding only. For use with Extension Feeding Set with ENFit connect…
EUDAMEDClass IIb (EU MDR)
Ref GH242510MERef GH242010MERef GH241710MERef GH242310ME
Identity
- Trade Name
- For Enteral Feeding only. For use with Extension Feeding Set with ENFit connectors. It is highly recommended to consult the instructions before use EUDAMEDFor Enteral Feeding only. For use with Extension Feeding Set with ENFit connectors. It is highly recommended to consult the instructions before use. EUDAMED
- Device Name
- Low-Profile Gastrostomy Replacement Tube (G. Button) Kit EUDAMED
- Model / Reference
- GH242510ME EUDAMEDGH242010ME EUDAMEDGH241710ME EUDAMEDGH242310ME EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18586026083559 EUDAMED18586026083535 EUDAMED18586026083528 EUDAMED18586026083542 EUDAMED
- Basic UDI-DI
- 602147GBUTTON5G EUDAMED
- EMDN Code
- G02020201 GASTROSTOMY, TUBES AND SETS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Slovakia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Gastrostomy tube
For Enteral Feeding only. For use with Extension Feeding Set with ENFit connect… by Sky Medical a.s. — Class IIb — MDR — listed in EUDAMED
Similar devices
Also classified as Gastrostomy tube.
- Balloon G-Tube — Applied Medical Technology, Inc. · Class II
- Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection — Xeridiem Medical Devices · Class II
- AMT Balloon G-Tube — Applied Medical Technology, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- Kangaroo — Cardinalhealth · Class II
- Gastrostomy Tube — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- EndoVive™ Low Profile Replacement Button — Boston Scientific · Class II
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 602147GBUTTON5G | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sky Medical a.s.
- EUDAMED SRN
- SK-MF-000001475
Sources (4)
- EUDAMED 919b648b-9c3c-4489-a0fb-e928bb6b68ad 61 fields · synced Oct 6, 2026
- EUDAMED 149c73ea-12b3-4008-9e8e-dbb0c41838bd 61 fields · synced May 17, 2026
- EUDAMED 3221af14-3666-4d42-ba9c-ede1f612141c 61 fields · synced May 17, 2026
- EUDAMED 4787c481-9fa0-488f-aa19-8df1c52e1300 61 fields · synced May 18, 2026